Dr KasturiLal

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

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

A CONTROLLED TRIAL OF LEPTADEN IN LACTATIONAL FAILURE AND AN EXPERIMENTAL STUDY IN LACTATING RATS

by Dr. KASTURI LAL, M.S., D.G.O., F.I.C.S. Professor & Head of Unit II, Department of Obstetrics & Gynaecology,

Mr. BHUPINDER SINGH M.Sc., D.B.A. Scientific Assistant, Discipline of Pharmacology, Regional Research Laboratory, C.S.I.R.

Dr. YUDHISHTER VIR'GUPTA, M.B.B.S.

Dr. BHUPINDER SINGH, M.B.B.S.

Dr. C.N. TIKU, M.B.B.S.

Mr. D.S. JAMWAL, M.Sc., Lecturer in Biochemistry, Govt. Medical College & S B G S Hospital, Jammu



The Indian Practitioner Volume XXXIII No. 10 Pages 557 To 564

LEPTADEN, an indigenous drug consisting of Kamboji (Breynia patens) and Jeevanti (Lep­tadenia reticulata), has been widely used for its gaiactopoietic, lactogenic and galactokinetic actions for initiation, stimulation and discharge of milk in cases of lactational failure or defi­ciency. (Gokhale2, Gupta et al5). The drug is re­ported to act within 8-12 hours of its administra­tion

In this study, direct evidence of the action of Leptaden is derived from clinical observations of milk flow and the analyses of protein, fat and carbohydrate constituents of breast milk of the study group and the controlled group. A col­laborative experimental study in lactating rats of two groups, one consisting of the Drug Group and the other, Controlled Group, was con­

ducted to see whether there is any correlation of results between the clinical trial and experi­mental study.

 

PATIENTS AND METHOD

(1) Clinical Study on Puerperal Mothers

This study was on two groups, one group consisting of 50 mothers who received 'Lepta­den and another group consisting of 50 mothers who received placebo. The mothers of the study group received Leptaden 2 tablets, three times a day, for 7 days, followed by a maintenance dose of 2 tabs. two times a day for a further period of 14 days. The control group of mothers received the placebo in the same dos­age and for the same period. The interval bet­ween the administration of the drug/placebo

and its effect on lactation was noted. Samples of breast milk were taken, first on 8-10 hours after administration of the drug/placebo and the second one 5-7 days after therapy. The milk samples of both the groups were analysed for protein, fat and carbohydrate (Lactose). Serial estimation of weight gain of the infants of both the groups was done throughout the trial period of 21 days.

(2) Experimental Study in Rats

Lactating rats were divided into two groups, one group forming the study group of 14 mothers with a combined total of 112 litters and the control group consisting of equal number of mothers and their litters. The average weight of the mothers in study and control groups was 193 ± 8 gm and 197 ± 8 gm respectively. The study group of lactating rats received 112 a tab­let of Leptaden daily in normal feed for three weeks while the control group did not receive any drug, but were maintained on identical con­ditions as to feeds etc. The weight gain among the litters of both the groups was serially re­corded for three weeks and the results were put to statistical analysis.

 

OBSERVATIONS

Condition of Lactation before the trial:

Cases of deficient or failure of lactation only were included in this trial. There were 38 cases of deficient lactation and 12 cases of failure of lactation in each group.

TABLE I Condition of Lactation in Mothers

Lactation

Leptaden  Group

Control Group

Deficient

38

38

Absent

12

12

Total

50

50

 

 

 

 

FLOW OF MILK IN LEPTADEN AND CONTROL GROUPS

There was an appreciable improvement in the flow of milk in all the 38 cases (100%) of de­ficient lactation of the Leptaden Group. In con­trol group of deficient lactation, improved lacta­tion was seen only in 3 cases (7.9%). Among 12 cases of failure of lactation of the Leptaden group, there was initiation of lactation in 10 cases (83.3%) and lactation became well es­tablished in a week's duration. Among 12 cases of failure of lactation of the control group, initia­tion of lactation was observed only in 2 cases (16.7%) and it was still deficient after a week to meet the needs of a suckling child.

Among the total of 50 cases of the Leptaden group of deficient or failure of lactation, im­provement was observed in 48 cases (96%) and no improvement was seen in 2 cases (4%). Among the total of 50 cases of the control group of deficient or failure of lactation, improvement was observed only in 5 cases (10%) and no im­provement was seen in 45 cases (90%).

 

TABLE II

Flow of Milk in Leptaden and Control Groups

Group

No.

Improved

%

Initiation

%

No. lm-

%

 

cases

lact

 

of lact.

 

provement

 

Leptaden-Deficient

 

 

 

 

 

 

 

lactation

38

38

100%

-=-~

-

0

 

Leptaden-failure

 

 

 

 

 

 

 

of lactation

12

 

 

10

83.3%

2

16.7%

Total

50

38

76%

10

20%

2

4%

Control-Deficient

 

 

 

 

 

 

 

lactation

38

3

7.9%

-

-

35

92.1%

Control failure of

 

 

 

 

 

 

 

lactation

12

 

 

2

16.7%

10

83.3%

Total

50

3

6%

2

..4%

45

90%

 

WEIGHT GAIN IN CHILDREN

There was weight gain of children of the Lep­taden group by 0.230 kg. (mean) whereas in the

control group, there was weight gain of 0.100 Kg. (mean).

TABLE III

Weight Gain in Children of the Leptaden Group and Control Group

Group

Initial weight

(mean)

Final weight

 

Weight Gain (mean)

(mean)

Control Group

2.750 Kg.

2.850 Kg-

0.100 Kg.

Leptaden Group

2.620 Kg.

2.850 Kg.

0.230 Kg.

 

ANALYSIS OF PROTEINS, FAT, CARBOHYDRATE (LACTOSE) OF BREAST MILK OF LEPTADEN AND CONTROL GROUPS

The first sample of breast milk was taken 8­10 hours after the administration of Leptadenl Placebo and the next sample was taken bet­ween 5-7 days of administration. There was an appreciable increase in fat content of breast milk in both the groups, but the rise was more (+ 1.26 gm/100 ml.) in the Leptaden group when compared to the Control group (+ 0.901 100 ml). There was a fall in the protein content of both the groups but, the fall was less in the Leptaden group (-1.17) gm/1 00 ml.) when com­pared to the fall in the control group (-1.60) gm/ 100 ml.).

TABLE IV

Leptaden Group

 

Constituent

1 st reading

gm/1 00 ml

 

2nd reading

gm/100 MI.

increase or decrease

gms/1 00 ml

Proteins °

3.86

2.69

- 1.17

Fat

3.14

4.40

+ 1.26

Carbohydrate

5.80

5.90

+0.10

Control Group

 

 

 

Proteins

4.20

2.60

- 1.60

Fat

3.30

4.20

+0.90

Carbohydrate

5.52

5.63

+0.11

 

EXPERIMENTAL STUDY OF WEIGHT GAIN IN LITTERS OF RATS

In the experimental study of lactating rats when Leptaden was given, the litters (112) showed significant weight gain from week to week (Fig. 1).

 

The mean percentage of weekly difference in weight increase between the drug treated and control groups was 36, 40 and 32.4 in the 1 st, 2nd and 3rd week respectively. Thus, there was a gross weight increase in the drug treated group by 80 percent in the first week, 72 per cent in 2nd week and 51 percent in 3rd week as compared to the control group. Statistically, comprising weekly weight gain of litters, the re­sults show that Leptaden has galactopoietic, lactogenic and galactokinetic actions and are statistically highly significant, (P < O.OA1),1 MEAN % OF WEIGHT INCREASED AS COMPARED TO CONTROL

 

 

 

 

 

TABLE V

Effect of Leptaden on the growth of rats litters through lactation

MEAN VALUE OF WEIGHT RECORD

 

Weight on

Drug Treated Group

Control Group

 

Mean Weight

± SE (gm)

Mean wt

± SE (gm)

P. Value

Birth

7.45

± 0.24

7.49

± 0.23

 

1st Week

17.22

± 0.79

12.67

± 0.44

< 0.001

2nd Week

23.66

± 0.69

16.91

± 0.51

< 0.001

3rd Week

27.44

± 0.66

20.72

± 0.42

< 0.001

 

DISCUSSION

The data of these studies indicate that com­pared to the control group, the babies of Lepta­den group of patients and rat litters show an appreciable weight gain. Leptaden was adminis­tered only to those patients who had deficient lactation and those having absence of lactation. There was significant improvement in the flaw of milk within 24 hours of administration of Lep­taden although the exact mechanism of its ac­tion is not known.

 

SUMMARY

 

This study was undertaken to determine the galactopoietic, lactogenic and galactokinetic actions of Leptaden in puerperal women and lactating rats. It was observed that there was appreciable gain in weight in the babies of treated groups as compared to control groups. In animal experiments on rats, the results were significant (P < 0.001). There was marked im­provement in the flow of milk in the treated group. Mothers treated with Leptaden showed better maintenance of fat (increased fat con­tent) and proteins (less fall in protein content) when compared to the control group of mothers. Majority in whom there was absence of lactation, showed stimulation of lactation in the Leptaden group while it was not so in the un­treated mothers. As such the usefulness of Leptaden as a galactopoietic, lactogenic and galactokinetic agent has been shown by clinical study in mothers and by experimental study in lactating rats, and by statistical analysis.

 

ACKNOWLEDGEMENT

     We are thankful to Mls. Alarsin Pharmaceut­icals, Bombay for their co-operation.

REFERENCES

1. Deshpande, Malti and Manju Asher, "Mys­tery of Lactation - A Clinical Study)". Antiseptic, 59:11. (1962)

2. Gokhale, Kllalti, "A Herbal Drug that stimu­lates Lactation" - Ind. Pract.18:12. (1965)

3. Hab1a, Akthar and Sitaratna, "Leptaden - A Clinical trial as a Galactagogue". Antiseptic, 69: 5. (1972)

4. Jyoti Kothari and Meena Kothari, "Breast Feeding & Leptaden". 48th All India Med. Conf., Ahmedabad. (1972)

5. Kusum Gupta & Naval Kishore, "Lactation - A Clinical Trial with Leptaden, A Herbal Drug". Antiseptic, 63:10. (1966)

6. Manda Purandare et al "Study of composi­tion of Breast milk & the Effect of Leptaden on-the quality of breast milk". - XV Interna­tional Congress of Paed., New Delhi, Oct. 23-29. (1977)

7. Padma Rao and H. L. Devi, "Effect of Lepta­den on Lactation", Antiseptic, 74: 4. (1977)

8. Trivedi, "Can Lactation be stimulated", Ind. Pract. 9: 2. (1977)

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