for the use only of a registered medical practitioner or a hospital or a laboratory.

Paper Presented at First Asian Congress of Induced abortion and voluntary sterilisation 4-9 March 1979 - Bombay

    -The Medicine & Surgery, Vol. No. XXV, No. 4, PP i-4, April 1985

A CONTROLLED TRIAL OF ALOES COMPOUND* IN CASES OF STERILITY AND MENSTRUAL IRREGULARITY.

BY

Dr. (Mrs.) S. Agrawal
Mo., D.G.o.Associate Prof. in Obstetrics & Gynaecology,
Govt. Medical College, NAGPUR 440 009, Maharashtra.

 

INTRODUCTION

When we are faced with the problem of menacing population growth, it is strange to see that the problem of infertile couples is confront­ing us more and more. One of the most vexing problems of gynaecology is the management of a sterile couple, and in particular, where no de­finite cause is found. About 10-15% of couples fail to conceive even though both the partners are normal and where all organic causes are excluded. These couples are termed as having "Low Fertility Index".

 

ALOES COMPOUND

Aloes Compound was selected for this study. Since the dawn of history a number of species of Aloes are put to various uses. Gjers­ted and Riner (1968) have described the use of Aloes as curative, cosmetic and a bitter ap­petizer. Aloes Compound contains Aloes (Aloes Indica), Hira Bol (Balsamodendron Myrrh), Kasis Bhasma (Iron Bhasma), Manjishta (Rubia cordifolia), Hurmal (Pegunum harmala), Kamboji (Breynia patens), and Jeevanti (Leptadenia reticulata). These in­TABL

gredients act synergistically as an em­menagogue, haematinic, sedative, antispas­modic and appetizer.

 

MATERIALS & METHODS

For this study cases of Primary & Secondary Sterility that attended the Govt. Medical Col­lege Hospital, Nagpur during the period Feb­ruary 1974 to December 1975, were taken at random. Only those cases that could be fol­lowed-up regularly for two years were included in the study.

The trial (Aloes Compound) Group consisted of 120 cases comprising 60 cases of Primary Sterility and 60 cases of Secondary Sterility. 50 cases formed the Control Group, out of which 25 cases were of primary sterility and 25 cases were of Secondary Sterility.

 

MENSTRUAL PATTERNS: Trial Group

Among the 120 cases of the Trial (Aloes Compound) Group, 25 cases (20.8%), had oligomenorrhoea, 38 cases (31.7%) had Ir­regular periods, and 57 cases (47.5%) had Nor­mal periods. The details are given in Table No. 1.

 

Menstrual Pattern: Trail (Aloes Compound)   Group. N =120
Pattern	Primary Sterility	% Sterility	Secondary	°	I Total	%
1.Oligomemorrhoea	10	16.7%	15	25.0%	25	20.8%
2: Irregular Periods	20	33.3%	18	30..0%	38	31.7%
3. Normal Periods	30	50.0%	27	45.0%	57	47.5%
Total:	60	100.0%	60	100.0%	120	100.0%

 

MENSTRUAL PATTERNS: Control Group

Among the 50 cases of the Control Group, 8 cases (16%) had oligomenorrhoea, 16 cases (32%) had Irregular periods and 26 cases (52%) had Normal periods. The details of menstrual pattern of the Control Group are given in Table No. II.

TABLE-II Menstrual Pattern: Control Group. N = 50.

 

Pattern	Primary Sterility	% Sterility	Secondary	%	Total	%
1.Oligomenorrhoea	3	12.0%	5	20.0%	8	16.0%
2. Irregular Periods	10	40.0%	6	24.0%	16	32.0%
3. Normal Periods	12	48.0%	14	56.0%	26	52.0%
Total:	25	100.0%	25	100.0%	50	100.0%

 

DOSAGE OF ALOES COMPOUND

Aloes Compound was given to the Trial Group, 2 tabs. three times a day, continuously for a period of two years or till conception was suspected, if earlier. All the cases of the Trial and Control Groups received thyroid ¹/2 a grain, twice a day and Vitamin B Complex.

Results: Menstrual Improvement in the Trial Group

Out of 63 cases of menstrual irregularity of the Trial Group, 60 cases (95.2%) improved their menstrual pattern with Aloes Compound. The details as to o(igomenorrhoea and irregular periods in cases of primary and secondary sterility are given in Table No. 3.

Results: Menstrual Improvement in the Control Group

Out of 24 cases of menstrual irregularity of the Control Group, only 2 cases (8.3%) im­proved in the menstrual pattern. The details as to oligomenorrhoea and Irregular periods in Primary and Secondary Sterility are given in Table No.         4.

Result: Conception Rate: Trial Group

Among 120 cases of the Trial (Aloes Co.) Group 75 cases (62.5%) conceived and 45 cases (37.5%) did not conceive within the trial period of two years. 38.4% (out of 62.5%) con­ceived within 6-12 months, 14.1 % .in 18 months and 10% in 24 months. Conception rate was

better in cases of Primary Sterility (65%) when compared to cases of Secondary Sterility (60.0%).The details are given in Table No. 5.

Results: Conception Rate: Control Group

Among 50 cases of the Control Group 10 cases (20%) conceived and 40 cases (80%) did not conceive. Conception rate was better in cases of Secondary Sterility (24%) when com­pared to cases of Primary Sterility (16%). The details are given in Table No. 6.

Statistical Study: Conception

Conception took place in 75 cases of Aloes Compound Group and 10 cases of Control Group, a total of 85 cases. 45 cases of the Aloes Compound Group and 40 cases of the Control Group, a total of 85 cases did not con­ceive. It is hypothetically assumed that the re­sponse to Aloes Compound is no better than in Control cases. This is put to statistical test. Using Chi square test for 2 x 2 contingency ta­bles, it is found that the value is higher than those given in Tables at P < 0.001. As such the assumption is rejected and it is concluded that statistically Aloes Compound has beneficial ac­tion in promoting conception in cases of Prim­ary and Secondary Sterility. The details are given in Table No. 6.

TABLE-III Results. Aloes Compound Group: Menstrual Improvemnt. N = 25.

1.OLIGOMENORRHOEA

Condition	no. of cases	6M	%	12 M	%	18M	%	24M	%	Total Imp.	%	Not improve	%
Primary Sterility	10	8	80%	1	10%	1	10%	-	-	10	100%	-	-
Secondary Sterility	15	9	90%	2	13.3%	1	6.7%	1	6.7%	13	86.7%	2	13.3%
Total	25	17	68%	3	12%	2	8%	1	4%	23	92%	2	8%

 

2. IRREGULAR PERIODS. N =16

Condition	no. of cases	6M	%	12 M	%	18M	%	24M	%	Total Imp.	%	Not improve	%
Primary Sterility	20	8	40%	4	20%	6	30%	1	5%	19	95%	1	5%
Secondary Sterility	18	10	55.5%	6	33.3%	1	5.6%	1	5.6%	18	100%	-	-
Total	38	18	47.4%	10	26.3%	7	18.4%	2	5.3%	2	97.4%	1	2.6%

Total                63       35             13                   9                3                 60                     3

1 & 2

%                    100%   55.5%      20.6%            14.3%         4.8%          95.2%                4.8%         

Normal Period:   57

TABLE-IV :Results: Control Group: Menstrual Improvement. N = 8

1.OLIGOMENORRHOEA

Condition	no. of cases	6M	%	12 M	%	18M	%	24M	%	Total Imp.	%	Not improve	%
Primary Sterility	3	-	-	-	-	1	-	-		1	33.3	2	66.7%
Secondary Sterility	5	-	-	-	-	-	-	-	-	-	-	5	100.0%
Total	8	-	-	-	-	1	12.5%	-	-	1	12.5%	7	87.5%

 

2. IRREGULAR PERIODS. N =16

Condition	no. of cases	6M	%	12 M	%	18M	%	24M	%	Total Imp.	%	Not improve	%
Primary Sterility	10	-	-	-	-	1	-	-		1	10	9	90.0%
Secondary Sterility	6	-	-	-	-	-	-	-	-	-	-	6	100.0%
Total	16	-	-	-	-	1	6.3%	-	-	2	6.3%	15	93.7%

 

Total                24       -       -       -           -         1        1.3%    -       -       2        8.3%      22        91.7%

1 & 2

Normal Period   26

 

 

TABLE-V Conception Rate : Trial (Aloes Compound) Group

Types of cases	no. of cases	6M	%	12 M	%	18M	%	24M	%	Total conc	%	Not conc	%
Primary Sterility	60	12	20%	11	18.3%	9	15%	7	11.7%	39	65%	21	35%
Secondary Sterility	60	11	18.3%	12	20%	8	13%	5	8.3%	36	60%	24	40%
Total	120	23	19.2%	23	19.2%	17	14.1%	12	10%	75	62.5%	45	37.5%

 

TABLE-VI Conception Rate : Control Group

Types of cases	no. of cases	6M	%	12 M	%	18M	%	24M	%	Total conc	%	Not conc	%
Primary Sterility	25	2	8%	-	-	1	4%	1	4%	4	16%	21	84%
Secondary Sterility	25	1	4%	2	8%	1	4%	2	8%	6	24%	19	76%
Total	50	3	6%	2	4%	2	4%	3	6%	10	20%	40	80%

 

TABLE-VII : Conception: Statistical Study

 

Group                                  Conceived                   Not Conceived                                   Total

Aloes  Compound                   75                                  45                                               120

Control                                10                                  40                                               50

Total                                   85                                  85                                               170

          ­Chi Square test for 2 x 2 contigency table : P <0.001.        

Statistical Study: Conception

Conception took place in 75 cases of Aloes Compound Group and 10 cases of Control Group, a total of 85 cases. 45 cases of the Aloes Compound Group and 40 cases of the control Group, a total of 85 cases did not con­ceive. It is hypothetically assumed that the re­sponse to Aloes Compound is no better than in Control cases. This is put to statistical test. Using Chi square test for 2x2 contingency tables, it is found that the value is higher than those given in Tables at P < 0.001. As such the assumption is rejected and it is concluded that statistically Aloes Compound has beneficial ac­tion in promoting conception in cases of Prim­ary and Secondary Sterility. The details are given in Table No. 7.

 

SIDE EFFECTS AND TOXICITY

No side effects or toxicity were observed in the use of Aloes Compound.

CONCLUSION

With the use of Aloes Compound improve­ment in menstrual pattern was appreciable (95.2%). Conception rate was high (62.5%). Statistically, it is proved that Aloes Compound has beneficial action in promoting conception (P < 0.001). It is concluded that Aloes Com­pound, which is a nonhormonal drug can be be­neficially used to promote conception in cases of Primary and Secondary Sterility.

 

ACKNOWLEDGMENT

I am thankful to Dr. P.C. Bansal, Dean, Med­ical College, Nagpur, for permission to conduct this study and Dr. P. Bhattacharya, Associate Professor of Obst. & Gynec., for her kind sup­port. I also thank Alarsin Pharmaceuticals, Bombay, for their cooperation.

pound (3) D&CIAloes Compound with Inj. Placentrex" Medicine & Surgery, Vol. XXI: 7, pp. 22-26 July, 1981.

 

References

1. Balsara, Roshan R (1966): Sterility associated with Irregular and Scanty Menstruation (Use of Aloes Compound as an adjuvant): Indian Pract 1:1, pp. 123-125, Jan. 1966.

2. Gupta, Kusum (1972): `Aloes Compound (A herbal drug in Functional Sterility: XVI All India Obst. & Gynec. Cong. New Delhi, 10-12 March 1972:

3. Jhaveri, C.L.; Munim J.K.; Dass, P.G. (1972): "Clinical Evaluation if Infertility as­sociated with irregular Menstrual Cycles treated with an Indigenous preparation": XVI All India Obst. & Gynec. Cong:, New Delhi, 10­12. March 1972.

4. Khosla, Usha & Khosla, K.C. (1981): "Man­agement of Primar; & Secondary Sterility with (I) Aloes Compound (2) D&CIAloes Com­

5. Mukherjee, Krishna; Pande, M,; Mukherjee, Meena (1972): A trial of Aloes Compound (an indigenous drug) in cases of Sterility as­sociated with Menstrual Irregularity" XVI All India Obst. & Gynec. Congress New Delhi 10­12, March 1972.

6. Panda, B.C.; Pradhan, S.N. Parida, H.K. (198'0)"Aioes Compound an Ayurvedic Drug in the management of Female Infertility - A Con­trolled Study": 56th All India Med. Conf., Cut­tack, Orissa, 28-31, Dec. 1980.

7. Panda, Bishnu Charan; Pradhan, S.N.; Parida, H.K. (1981, 1982): "Aloes Compound in the Management of Female Infertility (A Com­parative Study with Hormones)": XXV All India Obst. & Gynec. Congress, Calcutta, 29-31, Dec. 1981; Medicine & Surgery, XXII : 5, pp. 41-43, May 1982.

8. Rajasekharan, N.; Vijaya, R.; Rani Uma (1975) `Trial with the Indigenous Drug Aloes Com­pound in Infertility': Antiseptic, Vol. 72: 2, pp. 451-457, Sept. 1975.

9. Sangamnerkar, A.V. (1979, 1979): `Aloes Compound in Sterility': 21st All India Obst. & Gynec. Congress, Cuttack, Orissa , 27-29 Dec. 1977; Antiseptic, 76: 1, pp. 22-27, Jan. 1979.

10. Shah, Bakula P. (1977, 1980): `Management of Primary & Secondary Sterility till delivery with Aloes Compound & Leptaden in the mofussil and rural areas in India' 21st All India Obst. & Gynec. Congress, Cuttack, 27-29, Dec. 1977; Antiseptic 77: 3, pp. 155-162, March 1980.

11. Shah, Bakula P.; Shah, Pramod H. (1980, 1982):"Non-hormonal Ayurvedic Drugs in the . treatment of Primary Infertility": 1st National Congress on Hormones and Human Repro­duction Bombay, 22-25, Nov. 1980; Cur, Med. Pract., Vol. 26:12, pp. 363-366, Dec. 1982

12. Sivaraman, Ramani; Kumari, Sujaya; Kannan, Usha; Dharthi (1976): `Aloes Compound in Sterility': Antiseptic, 73:7, pp. 366-370, July 1976.

for information of ALARSIN products please write to: ALARSIN Marketing Pvt. Ltd. Alarsin House, A132, Road No. 3, M.I.D.C., Andheri (E), Bombay-400 093.